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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, blood mixing and blood weighing
510(k) Number DK760743
Tradename DONORMATIC
Device Name Blood Mixing and Weighing Devices
Original Applicant
Lifeline Instruments, Inc.
1180 miraloma way, suite e
sunnyvale,  CA  94086
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received12/01/1976
Decision Date 12/06/1976
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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